Sexually transmitted diseases (STD) can be defined as diseases that can be transmitted from one person to another primarily during sexual intercourse activities and body contacts between an infected individual and an uninfected individual. There are currently over twenty-six (26) recognized STD's, including AIDS, Syphillis, Gonorrhea and Herpes. The contact sites believed to be the most reponsible for STD transmission are the genitals, rectum, mouth and hands. Because of the variety of sexual and related contacts between these contact sites, no single treatment of a single site is known to be fully effective in preventing the transmission of STD's.
A combination of microbicidal agents, cleansing agents and barriers for preventing the transmission of sexually transmitted diseases should be easy to use, reliable, pleasing to the senses and low in cost. More importantly, the materials and method must have a high effectiveness in preventing AIDS and other sexually transmitted diseases in a real life sexual encounters, not only a laboratory environment.
Current devices and methods to prevent the transmission of AIDS and other venereal diseases tend to fall into three categories. The first is a solid barrier, such as a condom or diaphragm or vaginal sponge, which attempts to prevent a portion of one partner's skin and body fluids from contact with the other partner's skin or body fluids. The second method is a chemoprophylaxis or antibiotic injection or oral administration, which attempts to suppress the activity of the microbial agents that enter the body and cause the sexually transmitted diseases. The final method is the use of coating fluids (foams, creams, jellies) on affected portions, which form a viscous barrier to microbes and reduce abrasion. Some combinations of these three basic methods are known, as well as in combination with other treatment objectives, for example, birth control foams combined with spermicide compounds, such as nonoxynol-9, that also act as anti-microbial agents.
These prior approaches have many limitations, primarily related to the uncontrolled variety of body and fluid contact sites before, during and after sexual activity, and the multiplicity of microbial agents involved. Although the first (barrier) method, if used properly, can significantly reduce the incidence of sexually transmitted diseases, it may increase irritation, allergic reactions, and introduce additional microbes. Since it is believed that at least some of the sexually transmitted diseases can only be transmitted through a break in the skin, these side effects might actually cause transmission of a disease which would otherwise not be transmitted.
Other limitations are also that the barrier does not protect uncovered portions at or near the genitals, such as the testicles or rectal area, or non-genital areas, such as the mouth and hands. These uncovered portions are also frequently in contact with the sexual partner or fluids from the sexual partner. In addition, placement and especially removal of a contaminated barrier can also transmit disease. Solid barriers have also been used in combination with anti-microbial agents and coating fluids. Although improved protection resulted, the microbial agent caused added irritations, allergies and candidiasis infections in a majority of users. In addition, this combined method still did not address some of the limitations previously noted, such as before and after contacts with exposed/contaminated but unprotected including: the mouth; hands; and paragenital areas.
Studies conducted on the effectiveness of various antimicrobial agents placed in the genital areas in preventing sexually transmitted diseases, including: sulfanomides, penicillins and tetracyclines have showed a decrease in the rates of some sexually transmitted diseases, but increases in the rates of non-gonoccal urethritis, anti-microbial resistances, and allergic reactions. Vaginal drying has also been noted in other studies. It was recognized that finding an antibiotic that can be totally effective against the variety of microbial agents involved in sexually transmitted diseases, (1) without side effects of repeated use and (2) in the variety of human contacts involved in sexual encounters would be unlikely, if not impossible, and recent research has concentrated in other areas. Many of the limitations previously discussed were also present, such the protection of non-genital surfaces.
The third (coating fluid) method, especially in conjunction with a spermicide with antimicrobial properties as well, have again shown decreased incidence in some sexually transmitted diseases, but significant side effects (irritations, allergies, and infections) were again observed.
None of the prior art known to the applicant incorporates treatment and protection of all of the paragenital and non-genital areas that may be involved during a sexual encounter. None of the prior art known to the applicant uses a mild, non-specific anti-microbial agent with no known side effects and derived from a natural element, either alone or in conjunction with barriers and/or viscous fluids. None of the prior art known to the applicant provides a combination of articles to be applied to all of the paragenital and non-genital areas to prevent the transmission of STD's. Although rinsing and douche of the genitals is known, none of the prior methods for preventing sexually transmitted diseases known to the applicant incorporate a douche and/or cleansing of the affected areas. Although other antiseptic mouth washes have been long known and used for therapeutic purposes, no prior method known to the applicant uses a mouthwash for preventing sexually transmitted disease.
In view of the rapid spread of the AIDS epidemic, what is urgently needed is a simple combination of devices and a method of prevention using these devices which does not require the use of costly pharmacopia and does not interfere with the enjoyment of the sexual encounter. It would also be beneficial to present these devices in a convenient package grouping all the elements necessary to quickly and effectively practice the preventive method.